Recall Z-0689-2012 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dio
| Date | Jan 11, 2012 (initiated Sep 22, 2011) |
| Status | Terminated |
| Reason | There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator. |
| Root cause | Device Design |
| Action | The firm, Maquet Getinge Group, sent an "PRODUCT RECALL URGENT-MEDICAL DEVICE REMOVAL ACTION" letter dated September 22, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed tocheck their remaining inventory; remove product immediately to prevent use; remove the boxes or individually pouched oxygenators in a secure area of their facility and notify their MAQUET representative (a representative will physically remove the recalled product and replenish the removed units); and complete and return the enclosed Product Removal Dispo |
| Quantity | 168 units |
| Distribution | Nationwide distribution: AL, CA, DE, DC, FL, GA, HI, IL, IN, LA, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100278 | QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA Maquet Cardiopulmonary, AG, Apr 30, 2010 |